The Clinical Efficacy of DFPP in Patients With AAGN

Zhi-Hong Liu, M.D.

Status

Terminated

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Treatments

Drug: CTX

Other: DFPP&CTX

Study type

Interventional

Funder types

Other

Identifiers

NCT02294344

NJCT1403

Details and patient eligibility

About

The clinical efficacy of double filtration plasmapheresis(DFPP) in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).

Full description

This is a single center, prospective, randomized,controlled study to compare the clinical efficacy of double filtration plasmapheresis (DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy versus IV-CTX pulse therapy in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).

Enrollment

14 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

a diagnosis of ANCA associated vasculitis(AAV), using criteria adapted from the disease definitions of the Chapel Hill consensus conference
serum positive ANCA and the ANCA level ≥100 relative unit/ml
with renal involvement and serum creatinine≥3 mg/dl
written informed consent had been provided.

Exclusion criteria

other secondary vasculitis
anti-glomerular basement membrane(GBM) positive
severe infection; hepatitis B antigenemia, anti- hepatitis C virus
immunodeficiency; or immunoglobulin G(IgG)<2g/l
life threatening
renal biopsy show globally sclerotic glomeruli>60% and normal glomeruli<10%
need renal replacement therapy for more than 4w
received large dose of methylprednisolone(MP),CTX,mycophenolate mofetil(MMF), plasmapheresis or intravenous immunoglobulin(IVIg) therapy.